Amplifiers of the immune system derived from white blood cells have been shown to amplify immune system response in human and animal subjects. As suggested, for example, by issued U.S. Pat. Nos. 4,616,079 and 4,468,379, and in copending U.S. patent application Ser. No. 183,905, now abandoned, such amplifiers appear to act on T-helper cells (T4 or T4.sup.+ or CD4 cells) in a way that causes them to produce chemical messengers whose effect is to increase the magnitude of or speed up the cell-mediated immune system response to antigens, mitogens, and other means for activating a cell-mediated immune system response. Indicia of this response include production of IL-2 and gamma-interferon, and potentiation or production of cytotoxic cells. The cited references concern the effects of amplifiers of the immune system on T cells and do not discuss B lymphocytes (B cells).
The term "amplifier of the immune system," as used in the preceding paragraph and elsewhere in this patent application (sometime termed "amplifiers" for short), is used in the same sense as that term is used in U.S. Pat. No. 4,710,380; that is a sense that corresponds to that generally understood for the term in the immunological art. The term refers to a product, which may or may not be a single molecular species, that increases (i.e., amplifies) one or more of the following aspects of an immune response in a human or other mammalian body--speed of onset, magnitude, or duration--where the response is nonspecific, the response is to one or more antigens to which the subject has hitherto or is concurrently exposed, the response is attributable to a function of the immune system rather than some other cause, and the response occurs after the introduction of such antigen.
U.S. Pat. No. 4,468,379 specifically refers to the use of amplifiers to augment or accelerate the formation of delayed hypersensitivity reactions to recall antigens. It is understood in the immunological art that such reactions are a reflection of the cell-mediated immunity in which the T4 (CD4) cells play a major role. Those skilled in the immunological art regard delayed hypersensitivity reactions as mediated by T cells, and not by B cells. B cells, and not T4 cells, are considered to mediate antibody (immunoglobulin) production. It is believed that there is no suggestion in the prior art that amplifiers produce results on B cells. (To be sure, it is known that certain T cells are required for the normal production of antibody, but it is generally accepted in the art that the subclass of T cells that affect antibody production are distinct from the subclass of T cells that mediate such cell-mediated immune system phenomena as delayed hypersensitivity reaction to recall antigens. It is believed also that there has been no suggestion in the prior art that a product affecting the activity of the one subclass would have any effect on the activity of the other subclass. In particular, there is no suggestion that amplification of T cell activity will have any effect on B cell activity, such as production of immunoglobulins.)
Thus, those skilled in this art consider that the production of antibodies (immunoglobulins) by B lymphocytes (B cells) in response to antigenic challenge is a separate aspect of immune system response from that aspect considered to involve T4 cells. This B-cell activity is the basis of immunization. At this time, it is common (and legally required in many or most states) routinely to immunize children against such diseases as diphtheria, pertussis, and typhoid (DPT), as well as measles, tetanus, mumps, and other diseases by administering vaccines to them. The B-cell reaction to vaccine is the production of appropriate immunoglobulins, which are intended to confer immunity against the disease. Generally speaking, a particular B cell will be differentiated to produce one particular type of antibody, and such production is caused by the presence in the body of one particular type of antigen. Hence, when a person (or other mammal) has been exposed to a number of different antigens, he, she, or it will have a number of different B cells that can produce their particular immunoglobulins when the appropriate antigen is present.
In some situations, the immune response to antigen is insufficient to confer immunity. That is, a quantity of immunoglobulins is generated (or a number of B cells are potentiated) that is insufficient to confer effective immunity. At other times, an excessive immune reaction may occur, which may be manifested at the time of immunization or later. Excess production of immunogloublins may also occur without human cause. Overproduction of immunoglobulins may cause tissue destruction and autoimmune diseases. It would be desirable to reduce excessive production of immunoglobulins so as to prevent these adverse effects. It is believed that the literature does not describe any practical means of achieving the foregoing result.
It is highly desirable from a medical standpoint to reduce overproduction of immunoglobulins in diseases where such overproduction is present. In particular, it is desirable to reduce the excessive production of immunoglobulins often associated with Acquired Immune Deficiency Syndrome (AIDS) and AIDS-Related Complex (ARC). It is well known that such excessive immunoglobulin production can lead to kidney failure, gangrene, and other highly adverse sequelae. Therefore, lowering abnormally high levels of immunoglobulins in the blood of such patients is therapeutically useful, just as lowering cholesterol levels in the blood of patients at risk for heart attach or stroke is considered therapeutically useful. Physicians, including the first-named inventor, who treat AIDS or ARC patients with very high immunoglobulin levels consider reduction of such levels to be therapeutically useful.